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BRIEF TITLE: Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors

Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors


  • Org Study ID: 2018-01
  • Secondary ID:
  • NCT ID: NCT03662204
  • NCT Alias:
  • Sponsor: Exact Sciences Corporation - Industry
  • Source: Exact Sciences Corporation

Brief Summary

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.

Detailed Description


Subjects who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with
any solid tumor. Subjects will have a blood sample collected at enrollment and provide
medical history prior to initiation of treatment. There will be no further follow-up.

Overal Status Start Date Phase Study Type
Recruiting August 23, 2018 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Biomarker Evaluation

Primary Outcome 1 - Time Frame: Point in time (one day) blood collection at enrollment

Condition:

  • Breast Cancer
  • Lung Cancer
  • Colorectal Cancer
  • Prostate Cancer
  • Bladder Cancer
  • Uterine Cancer
  • Kidney Cancer
  • Renal Pelvis Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Stomach Cancer
  • Ovarian Cancer
  • Esophageal Cancer

Eligibility

Criteria:
Inclusion Criteria:

1. Subject is male or female > 18 years of age.

2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate,
bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or<br/> esophageal cancer.

OR

Subject has suspicion of a primary malignancy of bladder, kidney/renal pelvis, or
ovarian cancer based on imaging.

3. Subject understands the study procedures and is able to provide informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.

Exclusion Criteria:

1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal
cell or squamous cell skin cancers).

2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample
collection.

3. Any treatment for the primary malignancy or sites of metastases. Subject may not have
started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or
other treatment and/or surgery prior to blood sample collection.

4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood
collection.

5. Less than 7 days between biopsy (other than FNA) of target pathology and blood
collection.

6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.

7. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Alexandra Massoud

Phone: 608-957-5652

Email: amassoud@exactsciences.com

Locations

Facility Status Contact
Scottsdale Medical Imaging Research
Scottsdale, Arizona 85258
United States
Recruiting Courtney Clark
480-425-4271
coclark@esmil.com
Arizona Clinical Research Center, Inc.
Tucson, Arizona 85715
United States
Recruiting Patricia Plezia
520-290-2510
mmodiano@acrcresearch.com
Urological Associates of Southern Arizona, PC
Tucson, Arizona 85741
United States
Recruiting Maria Smith

marias@uasapc.com
Mercy Research-Fort Smith
Fort Smith, Arkansas 72903
United States
Recruiting Cheryl Hyde
479-314-5089
cheryl.hyde@mercy.net
Genesis Cancer Center
Hot Springs, Arkansas 71913
United States
Recruiting Laura Sellers
501-624-7700
lsellers@genesiscancercenter.com
NEA Fowler Family Center for Cancer Care
Jonesboro, Arkansas 72401
United States
Recruiting Emily Carvell
870-936-7066
emily.carvell@bmhcc.org
CARTI Cancer Center
Little Rock, Arkansas 72205
United States
Recruiting Carla Randall
501-906-3012
CRandall@CARTI.com
John Muir Clinical Research
Concord, California 94520
United States
Recruiting Suzanne Clements
925-674-2437
Suzanne.Clements@johnmuirhealth.com
Marin Cancer Care
Greenbrae, California 94904
United States
Recruiting Jamie Chang
415-925-5000
jchang@marincancercare.com
Alliance Research Centers
Laguna Hills, California 92653
United States
Recruiting Justin Deck
949-680-3490
jdeck@researchalliance.com
Office of John Homan, MD
Newport Beach, California 92663
United States
Recruiting Philomena Onorato
760-421-2993
m.clinicaltrials@gmail.com
North County Oncology
Oceanside, California 92056
United States
Recruiting Yumiko Kawai
760-721-8597
ncoyumi@gmail.com
UCI Department of Urology
Orange, California 92868
United States
Recruiting Nyles Oune
714-456-8131
nyles@uci.edu
Adventist Health - Saint Helena Hospital
Saint Helena, California 94574
United States
Recruiting Shalese Canby
707-967-5831
canbysr@ah.org
Sharp Memorial Hospital
San Diego, California 92123
United States
Recruiting Stephanie Manoff
858-939-5063
stephanie.manoff@sharp.com
St. Joseph Heritage Healthcare
Santa Rosa, California 95403
United States
Recruiting Camille Shaffer
707-521-3830
camille.shaffer@stjoe.org
Innovative Clinical Research Institute
Whittier, California 90603
United States
Recruiting Kirsten Bettino
562-693-4477
kbettino@airesearch.us
RMR VA Medical Center
Aurora, Colorado 80045
United States
Recruiting Caitlin Hutchinson
720-723-5663
caitlin.hutchinson2@va.gov
The Urology Center of Colorado
Denver, Colorado 80211
United States
Recruiting Chris Lightsey
303-762-7154
clightsey@tucc.com
Middlesex Hospital
Middletown, Connecticut 06457
United States
Recruiting Deborah Pantalena
860-358-2028
deborah.pantalena@midhosp.org
Easter Ct Hematology and Oncology
Norwich, Connecticut 06360
United States
Recruiting Jim Chaplin
860-886-8362
Jchamplin@echoct.com
Stamford Hospital
Stamford, Connecticut 06904
United States
Recruiting Ian Goff
203-276-8449
igoff@stamhealth.org
Southeast Florida Hematology-Oncology Group, PA
Fort Lauderdale, Florida 33308
United States
Recruiting Marcia Jablonski
954-776-1800
mjablonski@sefhog.com
CSNF - Central Business Office
Jacksonville, Florida 32256
United States
Recruiting Jenni Bachhofer

Jenni.Bachhofer@CSNF.US
Jupiter Medical Center
Jupiter, Florida 33458
United States
Recruiting Deia Wilkes
561-263-5768
deia.wilkes@jupitermed.com
Mount Sinai Medical Center
Miami Beach, Florida 33140
United States
Recruiting Jessica Pimentel
305-535-3394
jessica.pimentel@msmc.com
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United States
Recruiting Harish Gowda

harish@clorene.org
Sarasota Memorial Hospital
Sarasota, Florida 34203
United States
Recruiting Jon-Michael Eckert
941-917-4797
jon-michael-eckert@smh.com
University Cancer & Blood Center, LLC
Athens, Georgia 30607
United States
Recruiting Shameka Finch
706-353-2990
sfinch@universitycancer.com
Piedmont Cancer Institute, PC
Atlanta, Georgia 30318
United States
Recruiting Derrick Carter
678-298-3238
dcarter@piedmontcancerinstitute.com
Candler Hospital
Savannah, Georgia 31405
United States
Recruiting Judy Miller
912-819-5724
millerju@sjchs.org
Lewis Hall Singletary Oncology Center
Thomasville, Georgia 31792
United States
Recruiting Tiffany Woolum

tfwoolum@archbold.org
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois 60612
United States
Recruiting Karen Carter
312-864-7260
tlad@cookcountyhhs.org
PMG Research of DuPage Medical Group
Downers Grove, Illinois 60515
United States
Recruiting Peri Todd
630-545-7760
peri.todd@pmg-research.com
Presence Cancer Care / JOHA
Joliet, Illinois 60435
United States
Recruiting Karen Sceniak
815-730-3098
ksceniak@jolietoncology.com
Illinois CancerCare, P.C.
Peoria, Illinois 61615
United States
Recruiting Nancy Williams
309-243-3614
nwilliams@illinoiscancercare.com
Orchard Healthcare Reasearch Inc
Skokie, Illinois 60077
United States
Recruiting Joy Jardinico

jjardinico@orchardhr.com
SIU School of Medicine
Springfield, Illinois 62702
United States
Recruiting Candace Griffith
217-545-0031
cgriffith42@siumed.edu
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana 46260
United States
Recruiting Zara Anderson
317-297-2208
zanderson@investigativeicr.com
PMG Research of McFarland Clinic
Ames, Iowa 50010
United States
Recruiting Erin Hackett
336-608-3500
Des Moines Oncology Research Associate
Des Moines, Iowa 50309
United States
Recruiting Debora Carlson
515-241-3305
dcarlson@iora.org
St. Elizabeth's Edgewood Cancer Care Research
Edgewood, Kentucky 41017
United States
Recruiting Adrienne Snow
859-301-4735
john.losey@stelizabeth.com
Baptist Health-Lexington
Lexington, Kentucky 40503
United States
Recruiting Jeanna Alexander
859-260-6369
jeanna.alexander@bhsi.com
Norton Cancer Institute-Pavilion
Louisville, Kentucky 40202
United States
Recruiting Catherine Conway
502-629-2500
catherine.conway@nortonhealthcare.org
Baptist Health
Louisville, Kentucky 40207
United States
Recruiting Patricia Kelly
502-721-6012
patricia.kelly1@bhsi.com
Baptist Health- Paducah
Paducah, Kentucky 42001
United States
Recruiting Betty Kuiper
270-575-2928
bkuiper@bhsi.com
Greater Baltimore Medical Center
Baltimore, Maryland 68506
United States
Recruiting Judy Bosley
443-849-3122
jbosley@gbmc.org
Holy Cross Hospital Resource Center Department of Cancer Research
Silver Spring, Maryland 20902
United States
Recruiting Lyudmila Kalnitskaya
301-754-7552
kalnitsl@holycrosshealth.org
Beverly Hospital, Oncology
Beverly, Massachusetts 01915
United States
Recruiting Jacqueline Broms
978-381-7403
jacqueline.m.broms@lahey.org
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Recruiting Katherine Hesler
617-726-2153
khesler@mgh.harvard.edu
Lowell General Hospital
Lowell, Massachusetts 01854
United States
Recruiting Clay Hardeman
978-788-6518
Clay.Hardeman@lowellgeneral.org
Cancer and Hematology Centers of Western Michigan, PC
Grand Rapids, Michigan 49503
United States
Recruiting Lynn Metz
616-954-5550
lmetz@chcwm.com
Cancer Research Consortium of West Michigan (CRCWM)
Grand Rapids, Michigan 49503
United States
Recruiting Anthony Hicks
616-391-1230
anthony.hicks@crcwm.org
Ascension Providence Hospitals
Southfield, Michigan 48075
United States
Recruiting Rhonda Forster
248-849-5330
rhonda.forster@ascension.org
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota 55416
United States
Recruiting Elizabeth Wagner

elizabeth.wagner@parknicollet.com
Park Nicollet Institute - Oncology Research
Saint Louis Park, Minnesota 55426
United States
Recruiting Janet Morgan

janet.morgan@parknicollet.com
St. Dominic's Gynecologic Oncology
Jackson, Mississippi 39216
United States
Recruiting Janet Humphreys
601-200-4479
jhumphreys@stdom.com
North Mississippi Medical Center Hematology and Oncology
Tupelo, Mississippi 38801
United States
Recruiting Anthony Summerford
662-377-4629
aqsummerford@nmhs.net
Mercy Cancer Center
Joplin, Missouri 64804
United States
Recruiting Leah Klink
417-556-3980
leah.klink@mercy.net
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United States
Recruiting Chris Sanders
314-996-5802
chris.sanders@bjc.org
Mercy Hospital
Saint Louis, Missouri 63141
United States
Recruiting Alesia Bell
314-251-7993
alesia.bell@mercy.net
Mercy Cancer and Hematology Clinic
Springfield, Missouri 65804
United States
Recruiting Jennifer Khars
417-820-4587
jennifer.kahrs@mercy.net
Nebraska Hematology-Oncology -- Lincoln
Lincoln, Nebraska 68506
United States
Recruiting Kristina Benson
402-484-4908
kbenson@yourcancercare.com
Somnos Laboratories, Inc.
Lincoln, Nebraska 68510
United States
Recruiting Greg Rugh
402-486-3430
greg@somnos.com
Cancer Care Specialists
Reno, Nevada 89519
United States
Recruiting Amy Munoz
775-329-0222
amyy@ccsreno.com
The Minniti Center for Hematology and Oncology
Mickleton, New Jersey 08056
United States
Recruiting Karen Swenson
856-423-0754
swensonk@ihn.org
Riverview Medical Center
Red Bank, New Jersey 07701
United States
Recruiting Arshia Shaikh
732-450-2722
arshia.shaikh@hackensackmeridian.org
Albany Medical College
Albany, New York 12208
United States
Recruiting Brenda Romeo
518-262-8579
AMCUrologyResearch@amc.edu
Brooklyn Urology Research Group
Brooklyn, New York 11201
United States
Recruiting Melanie Camacho

Mcamacho.burg@gmail.com
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Krysten Stoll
716-845-8270
krysten.stoll@roswellpark.org
Hematology Oncology Associates of Central New York
East Syracuse, New York 13057
United States
Recruiting Kelly Cohn
315-472-7504
kcohn@hoacny.com
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York 12601
United States
Recruiting Lisa Crespi
845-437-5010
lcrespi@premiermedicalhv.com
Premier Medical Group of the Hudson Valley, PC Research Department - Gastroenterology Division
Poughkeepsie, New York 12601
United States
Recruiting Alyson Cahill
845-451-7262
acahill@premiermedicalhv.com
Richmond University Medical Center
Staten Island, New York 10310
United States
Recruiting Adnan Nasir
510-512-8994
dradnans@hotmail.com
Stony Brook Cancer Center
Stony Brook, New York 11794
United States
Recruiting Kim Lyktey
631-638-1000
kim.lyktey@stonybrookmedicine.edu
Associated Medical Professionals
Syracuse, New York 13210
United States
Recruiting Sarah Faisal

SFaisal@ampofny.com
Cone Health Cancer Center
Greensboro, North Carolina 27403
United States
Recruiting Cameo Windham
336-832-0825
phonacelle.windham@conehealth.com
PMG Research of Hickory, LLC
Hickory, North Carolina 28601
United States
Recruiting Jennifer Lail

jlail@pmg-research.com
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina 28374
United States
Recruiting Pam Mason
910-715-4434
pmason@firsthealth.org
PMG Research of Rocky Mount
Rocky Mount, North Carolina 27804
United States
Recruiting Brandi Vincent
336-608-3500
brandi.vincent@pmg-research.com
PMG Research of Piedmont
Statesville, North Carolina 28625
United States
Recruiting Katherine Sanders

Katherine.Sanders@pmg-research.com
Marion L. Shepard Cancer Center
Washington, North Carolina 27889
United States
Recruiting Kristy Alligood
252-974-9389
Kristy.Alligood@VidantHealth.com
Zimmer Cancer Center
Wilmington, North Carolina 28402
United States
Recruiting Deirdre Kilcommons
910-667-4080
deirdre.kilcommons@seahec.ne
Hematology & Oncology Associates, Inc.
Canton, Ohio 44708
United States
Recruiting Joan Kaufman
330-489-1274
joan.kaufman@cantonmercy.org
Tri-County Hematology & Oncology Associates, Inc.
Massillon, Ohio 44646
United States
Recruiting Joan Kaufman
330-489-1274
joan.kaufman@cantonmercy.org
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma 73505
United States
Recruiting Susie McCoy
580-536-2121
susie.mccoy@ccswok.org
Genie Jackson Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Bailey Jordan
405-271-8777
bailey-jordan@ouhsc.edu
Mercy Oncology Research
Oklahoma City, Oklahoma 73120
United States
Recruiting Christopher Thompson

patricia.strubhar@mercy.net
St. Luke's University Health Network
Bethlehem, Pennsylvania 18015
United States
Recruiting Jessicca Rosario
484-526-7952
Jessicca.rosario@sluhn.org
Women & Infants Hospital
Providence, Rhode Island 02905
United States
Recruiting Ann John
401-274-1122
ajohn@wihri.org
Charleston Cancer Center
Charleston, South Carolina 29406
United States
Recruiting Ashley Moultrie
843-576-1024
AshleyA@CharlestonCancer.com
McLeod Center for Cancer Treatment and Research
Florence, South Carolina 29506
United States
Recruiting Dorie Sturgill
843-777-5929
peri.todd@pmg-research.com
Saint Francis Cancer Center Research Department
Greenville, South Carolina 29607
United States
Recruiting Taylor Crowe
864-603-6247
ashley_crowe2@bshsi.org
Lowcountry Urology/PMG Research of Charleston, LLC
North Charleston, South Carolina 29406
United States
Recruiting Kathleen Walker

Kathleen.Walker@pmg-research.com
Spartanburg Medical Center: Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina 29303
United States
Recruiting Tom Leuck
864-560-1060
hfarmer@gibbscc.org
Lexington Medical Center
West Columbia, South Carolina 29169
United States
Recruiting Linda Sherriff
803-935-8374
ldsherriff@lexhealth.org
RH Clinical Research
Rapid City, South Dakota 57701
United States
Recruiting Angie Dunbar
605-755-2370
ADunbar@regionalhealth.org
PMG Research of Bristol, LLC
Bristol, Tennessee 37620
United States
Recruiting Amy Dye

adye@pmg-research.com
The Jackson Clinic
Jackson, Tennessee 38301
United States
Recruiting Ashley Childs
731-422-0362
achilds@jacksonclinic.com
Christus Spohn Cancer Center
Corpus Christi, Texas 78404
United States
Recruiting Melissa Shadle
361-861-9594
melissa.shadle@christushealth.org
University of Texas Health Science Center
Houston, Texas 77030
United States
Recruiting Sonia Robazetti

sonia.c.robazetti@uth.tmc.edu
San Antonio Military Medical Center
Houston, Texas 78234
United States
Recruiting Peggy Smith
210-916-3332
peggy.s.smith56.ctr@mail.mil
Sun Research Institute
San Antonio, Texas 78215
United States
Recruiting Beneta Parthiban
210-227-1289
bparthiban@sunresearch.com
Cancer Treatment Center
Texarkana, Texas 75503
United States
Recruiting Tammy Mckamie
903-614-2654
tammy.mckamie@christushealth.org
Renovatio Clinical
The Woodlands, Texas 77380
United States
Recruiting Talal Kayyal
713-703-2398
talal.kayyal@renovatioclinical.com
Community Cancer Trials of Utah
Ogden, Utah 84405
United States
Recruiting Shirley Waters

admin@communitycancertrials.com
Utah Cancer Specialists
Salt Lake City, Utah 84106
United States
Recruiting Marianne Herndon
801-270-2239
mherndon@utahcancer.com
Virginia Cancer Institute
Richmond, Virginia 23230
United States
Recruiting Sue Moore
804-287-3000
smoore@vacancer.com
Urology of Virginia, PLLC
Virginia Beach, Virginia 23462
United States
Recruiting Donna DeVenuto
757-452-3453
DonnaSchriner@urologyofva.net
Seattle Urology Research Center
Burien, Washington 98166
United States
Recruiting Angel Felipe

surc@comcast.net
MultiCare Regional Cancer Center
Tacoma, Washington 98405
United States
Recruiting Roslyn Pierce

rpierce@multicare.org
CAMC Clinical Trials Center
Charleston, West Virginia 25304
United States
Recruiting Christina Bethea
304-388-9679
Christina.bethea@camc.org
Mon Health Medical Center
Morgantown, West Virginia 26505
United States
Recruiting Karen Hunter
304-598-6581
hunterk@monhealthsys.org
West Virginia University Cancer Institute
Morgantown, West Virginia 26506
United States
Recruiting Rhonda Snyder
304-293-2633
rysnyder@hsc.wvu.edu
HSHS St. Vincent Hospital
Green Bay, Wisconsin 54301
United States
Recruiting Stuart Mohoney
920-433-8795
stuart.mohoney@hshs.org
Michael Berry Building-Oncology
Janesville, Wisconsin 53548
United States
Recruiting Ashli Huppert
608-756-6695
ahuppert@mhemail.org
UW Carbone Cancer Center
Madison, Wisconsin 53792
United States
Recruiting Ashley Reeson
608-265-7942
areeson@wisc.edu
ProHealth Care Research Institute
Waukesha, Wisconsin 53188
United States
Recruiting Julia Buska
262-928-5539
chanda.miller@phci.org